Buprenorphine hydrochloride

Details

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Generic Name:
buprenorphine hydrochloride
Project Status:
Complete
Therapeutic Area:
Opioid drug dependence, treatment
Manufacturer:
Knight Therapeutics Inc.
Call for patient/clinician input open:
Brand Name:
Probuphine
Project Line:
Reimbursement Review
Project Number:
SR0550-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Opioid drug dependence, treatment
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:

Key Milestones2

Call for patient input posted November 22, 2017
Patient group input closed January 18, 2018
Clarification:

- No patient input submission received

Submission received December 21, 2017
Submission accepted for review January 12, 2018
Review initiated January 15, 2018
Draft CADTH review report(s) sent to applicant April 03, 2018
Comments from applicant on draft CADTH review report(s) received April 12, 2018
Redaction requests from applicant on draft CADTH review report(s) received April 19, 2018
Clarification:

- No redactions requested by the applicant

CADTH review team's comments on draft CADTH review report(s) sent to applicant May 04, 2018
Canadian Drug Expert Committee (CDEC) meeting May 16, 2018
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans May 29, 2018
Embargo period ended and validation of redacted CADTH review report(s) received June 12, 2018
Clarification:

- Reconsideration requested

Applicant's request for reconsideration placed on CDEC agenda August 15, 2018
CDEC Final Recommendation issued to applicant and drug plans August 22, 2018
CDEC Final Recommendation posted August 24, 2018
Final CADTH review report(s) and patient input posted September 17, 2018